Article

OncoMed Halts Enrollment and Phase 1 Dosing Studies for Vantictumab and Fzd8-Fc

OncoMed Pharmaceuticals Inc. (Nasdaq:OMED), today announced that the company has voluntarily halted patient enrollment and dosing in its ongoing Phase 1 clinical trials of its two Wnt pathway inhibitor programs, vantictumab (anti-Fzd7, OMP-18R5) and Fzd8-Fc (OMP-54F28).

OncoMed has been informed by the participating clinical sites of recent on-target mild-to-moderate bone-related adverse events for the two programs. To date, bone-related adverse events have been observed in 8 of 63 (13%) patients treated with vantictumab and 2 of 41 (5%) patients treated with Fzd8-Fc. After careful analysis of the recent mild-to-moderate adverse event incidents, OncoMed has halted enrollment and dosing in the Phase 1 studies for both programs as a precautionary measure. OncoMed, in conjunction with its academic bone expert advisors and study investigators, continues to analyze the clinical data in order to submit amended protocols to the U.S. Food and Drug Administration (FDA) and subsequently to the clinical study sites.

Press release: http://bit.ly/1p9bHPS

Source: OncoMed

Related Videos
Wanmei Ou, PhD, vice president of product, data analytics, and AI at Ontada
Glenn Balasky, executive director of the Rocky Mountain Cancer Center.
Corey McEwen, PharmD, MS
dr linda bosserman
dr andrew leitner
Glenn Balasky during a video interview
dr joseph alvarnas
dr joseph alvarnas
Related Content
AJMC Managed Markets Network Logo
CH LogoCenter for Biosimilars Logo